Study to Determine Results of Vibratory Stimulus on Subje... | NCT01491828

Studies
Study to Determine Results of Vibratory Stimulus on Subject's Neck

NCT01491828

Sponsor

Kai Medical, Inc.

Status

Completed

Last Update Posted

Mar 20, 2012Estimated

Enrollment

100Estimated

Phase

Phase 1

Conditions

Sleep Apnea
Snoring

Interventions

Kai Strap

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Dec 10, 2011

First Submission Date that Met QC Criteria

Dec 13, 2011

First Posted Date

Dec 14, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2012

Last Update Posted Date

Mar 20, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement.

Detailed Description

This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement, and provide information regarding the optimum location and variable vibration parameters of vibratory stimulus on a subject's neck to cause head, neck, or jaw movement. The study will also provide information whether the subject experienced or did not experience a change in sleep stage or arousal by vibratory stimulus on a subject's neck. The data gathered from this study will be used for future studies in analyzing whether such vibratory stimulus can serve as a potential treatment for sleep disorders, such as snoring and obstructive sleep apnea.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Kai Strap	Device	Medical device component that vibrates on a subject's neck.		Kai Patch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Head, neck, or jaw movement	Movement of head, neck, or jaw as evidenced by manual observation and video camera.	1 month

Secondary Outcomes

Measure	Description	Time Frame
Affect of sleep stage	Electrocortical arousal caused by device as measured by EEG.	1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female, ages 18 to 80 years old
Able to provide written informed consent for themselves and comply with study procedures.

Exclusion Criteria:

Known hyposensitivity or hypersensitivity to vibrations on neck.
Neurological disorder such as seizure disorder or narcolepsy.
Psychiatric disorders currently not under control.
Insomniacs.
Pregnant women.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kelley Ford Shippey III, MD, MS		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kai Medical Sleep Lab		Honolulu	Hawaii	96816	United States

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes
D012913	Snoring
D001049	Apnea

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias

Browse Leaves

Not provided

Browse Branches

Not provided